|- candidate number||27828|
|- NTR Number||NTR6677|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-sep-2017|
|- Secondary IDs||2015-004937-29 EU Clinical Trials Register|
|- Public Title||Het effect van behandeling van uitgezaaide prostaatkanker met cabazitaxel meten met 18F-Choline PET-CT.|
|- Scientific Title||Towards early identification of response to CABAZItaxel in patients with metastatic castration-resistant prostate cancer: potential of 18F-Choline PET-CT.|
|- hypothesis||Cabazitaxel is a tubulin-binding taxane drug that improves survival of patients with docetaxel-metastatic-castration-resistant prostate cancer (mCRPC). Unfortunately, cabazitaxel is not effective in all patients and can have serious side effects. Therefore, early identification of responding patients might contribute to rational use of cabazitaxel. However, current methods (PCWG2 criteria) to measure response do not meet this need. |
Whole body 18F-fluorocholine positron emission tomography (FCH-PET) may qualify as early biomarker of response: PET visualizes and quantifies the uptake of radiolabeled choline; choline metabolism is typically enhanced in prostate cancer. The whole body feature of PET-CT allows for assessment of overall tumor load as well as of individual metastases. In preclinical work, we validated the use of FCH-PET as a potential response read-out to cabazitaxel. In clinical ground-work, we validated simplified PET quantitative measures for use in standard clinical practice, and defined the repeatability of these FCH-PET measures.
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Metastatic castrate-resistant prostate cancer (mCRPC), Cabazitaxel|
|- Inclusion criteria||1. ≥18 years of age|
2. Signed informed consent according to ICH-GCP before start of treatment and any study specific procedures
3. ECOG Performance Status 0-2
4. Histological or cytological confirmation of adenocarcinoma of the prostate.
5. Evidence of locally advanced disease, bone-, visceral and/or lymph node metastases on bone scan, CT-scan or MRI
6. Continued androgen deprivation therapy either by orchidectomy or GnRH agonist/antagonist
7. Serum testosterone level < 1.7 nmol/L (<50 ng/mL) within 21 days before treatment start
8. Disease progression occurring during or after completion of docetaxel treatment (+ADT) in hormone-sensitive setting or during or after completion of docetaxel treatment (as 1st line) in castration-resistant setting. Patients should have received adequate exposure to docetaxel, that is, not inferior to a cumulative dose of 225 mg/m˛. Disease progression to be defined as either (1) radiologic disease progression of osseous disease and/or of measurable lesions according to the Prostate Cancer Working Group 2 (PCWG2) criteria and/or (2) prostate-specific antigen progression according to the PCWG2 criteria and disease-related worsening of pain as judged by the treating physician.
9. Treatment with curative intent is not an option and patient has an indication for cabazitaxel as judged by the medical care provider.
|- Exclusion criteria||1. Impossibility or unwillingness to take oral drugs|
2. Geographical, psychological or other non-medical conditions interfering with follow-up
3. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus or active systemic or local bacterial, viral, fungal - or yeast infection)
4. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
5. Chemotherapy or immunotherapy (other than LHRH analogues) within the last 4 weeks before study inclusion
6. Prior treatment with cabazitaxel, abiraterone, enzalutamide or radium-223 post-docetaxel.
7. History of severe hypersensitivity reaction (≥grade 3) to docetaxel
8. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
9. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
10. Patients who have a concurrent yellow fever vaccination
11. Abnormal liver functions consisting of any of the following (within 21 days before start of treatment):
• Total bilirubin > 1 x ULN (except for patients with documented Gilbert’s disease);
• Alanine aminotransferase (ALAT/SGPT) and/or aspartate aminotransferase (ASAT/ALAT) > 1.5 x ULN
12. Abnormal hematological blood counts consisting of any of the following (within 21 days before start of treatment):
• Absolute neutrophil count < 1.5 x 109/L
• Platelets < 100 x 109/L
• Hemoglobin < 6.2 mmol/L (< 10.0 g/dL).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||8-sep-2017|
|- planned closingdate|
|- Target number of participants||30|
|- Interventions||Cabazitaxel (administered in context of standard clinical practice)|
|- Primary outcome||The main objective of this study is to assess the predictive value of FCH uptake changes as defined with FCH-PET after one cycle of treatment (vs. baseline). This, in order to predict the clinical response, as defined by PCWG2 criteria, to treatment of mCRPC with cabazitaxel|
|- Secondary outcome||Secondary objectives are to assess the predictive value of alternative PET measures, the interlesional concordance and the use of a single-lesion versus a multiple-lesion approach. |
|- Timepoints||A whole-body FCH-PET scan will be performed in 30 patients at baseline (within two weeks of treatment start) and after the first cycle of treatment with cabazitaxel.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| D.E. Oprea-Lager|
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Sanofi-Aventis, Cyclotron BV|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||6-sep-2017 - 12-sep-2017|